MED3000: FDA details the scope of confirmatory studyresults
Lighthouse | 22 October 2020
Trinity Delta view: Futura Medical has now had three constructive meetings with the FDA that clarified MED3000’s regulatory pathway. MED3000 is expected be the first clinically proven ED product that is approved for OTC use in Europe and the US. Its rapid onset of effect, undoubted safety, and ease of use suggest MED3000 would offer an attractive, clearly differentiated, and competitive clinical profile. Whilst risks clearly remain, the discussions with the regulatory bodies have been encouraging and supportive, which suggests the inevitable pre-approval questions should be relatively straightforward and timely to address. We value Futura Medical at £153.8m, equivalent to 60.9p a share.
22 October 2020
Futura Medical is an R&D driven small pharma company, with a novel DermaSys transdermal delivery platform. The lead programme, MED3000, a topically applied gel, is being developed for erectile dysfunction (ED). A pain relief gel, TPR100, is awaiting UK approval.
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